A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis



Status:Recruiting
Conditions:Parkinsons Disease, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:July 2010
Contact:Mary Aloisio
Email:maloisio@acadia-pharm.com
Phone:1-858-320-8620

Use our guide to learn which trials are right for you!

A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease


The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin
compared to placebo in patients with Parkinson's disease psychosis (PDP).


Inclusion Criteria:

- A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year

- Presence of visual and/or auditory hallucinations, and/or delusions, occurring during
the four weeks prior to study screening

- Psychotic symptoms must have developed after Parkinson's disease diagnosis was
established

- Subjects that are on anti-Parkinson's medication must be on a stable dose for 1 month
prior to Study Day 1 (Baseline) and during the trial

- Subject that has received stereotaxic surgery for subthalamic nucleus deep brain
stimulation must be at least 6 months post surgery and the stimulator settings must
have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain
stable during the trial

- The subject is willing and able to provide consent

- Caregiver is willing and able to accompany the subject to all visits

- Subject and caregiver are willing and able to adequately communicate in English for
the purposes of the primary assessment

Exclusion Criteria:

- Subject has a history of significant psychotic disorders prior to or concomitantly
with the diagnosis of Parkinson's disease including, but not limited to,
schizophrenia or bipolar disorder

- Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and
thalamotomy) to treat Parkinson's disease

- Subject has current evidence of a serious and or unstable cardiovascular,
respiratory, gastrointestinal, renal, hematologic or other medical disorder

- Subject has had a myocardial infarction in last six months

- Subject has any surgery planned during the screening, treatment or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study
participation are met. These evaluations will include specific measures of psychosis
severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may
be excluded from the study based on these assessments (and specifically if it is
determined that their baseline health and psychiatric condition do not meet all
protocol-specified entry criteria).
We found this trial at
26
sites
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Ashville, NC
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Helena, MT
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
?
mi
from
Lewiston, ME
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Santa Clara, CA
Click here to add this to my saved trials
?
mi
from
St. Joseph, MO
Click here to add this to my saved trials
?
mi
from
Warwick, RI
Click here to add this to my saved trials